Details for New Drug Application (NDA): 201150
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The generic ingredient in SILDENAFIL CITRATE is sildenafil citrate. There are twenty drug master file entries for this compound. Sixty-four suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.
Summary for 201150
Tradename: | SILDENAFIL CITRATE |
Applicant: | Mylan Pharms Inc |
Ingredient: | sildenafil citrate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201150
Mechanism of Action | Phosphodiesterase 5 Inhibitors |
Medical Subject Heading (MeSH) Categories for 201150
Suppliers and Packaging for NDA: 201150
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SILDENAFIL CITRATE | sildenafil citrate | TABLET;ORAL | 201150 | ANDA | Northwind Pharmaceuticals | 51655-721 | 51655-721-52 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-721-52) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Nov 9, 2012 | TE: | AB | RLD: | No |
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